BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORQR

    MDR report key: 2810933 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03753
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 20, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LPB
    PMA / PMN Number
    K915563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT DEVELOPED TAMPONADE DURING THE TRANSSEPTAL PUNCTURE AS THE PERICARDIUM WAS PUNCTURED. THE ABLATION DIAGNOSTIC CATHETER WAS NO LONGER USED AND THE CASE WAS STOPPED. THE PATIENT WAS SENT FOR OBSERVATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORQR ABLATION DIAGNOSTIC CATHETER LPB MEDTRONIC, INC. 041865CS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R